PMID- 29752913
OWN - NLM
STAT- MEDLINE
DCOM- 20181002
LR  - 20191210
IS  - 1873-3492 (Electronic)
IS  - 0009-8981 (Linking)
VI  - 483
DP  - 2018 Aug
TI  - Development and validation of a targeted affinity-enrichment and LC-MS/MS 
      proteomics approach for the therapeutic monitoring of adalimumab.
PG  - 308-314
LID - S0009-8981(18)30224-9 [pii]
LID - 10.1016/j.cca.2018.05.015 [doi]
AB  - BACKGROUND: The anti-tumor necrosis factor alpha (TNFalpha) therapeutic monoclonal 
      antibodies (mAbs), such as adalimumab, are widely used in the treatment of 
      rheumatoid arthritis, inflammatory bowel diseases, and other auto-immune 
      diseases. The administration of adalimumab can elicit the immune responses from 
      some patients, resulting in the formation of anti-drug antibodies (ADAbs). The 
      ADAbs can diminish the therapeutic effects of adalimumab by neutralizing the TNFalpha 
      binding site or increasing its clearance from circulation. METHODS: To 
      effectively monitor the therapeutic concentrations of adalimumab, we developed 
      and validated a targeted quantitative proteomic assay to determine the 
      circulating concentrations of adalimumab. Since drug effects can be attenuated by 
      ADAbs, the method adopted an affinity-enrichment step to selectively quantify the 
      bioavailable forms of adalimumab in patient serum samples. RESULTS: The 
      performance of the LC-MS/MS based assay provides the analytical measuring range 
      and precisions applicable for the therapeutic monitoring of adalimumab. It also 
      provides comparable results to a cell-based activity assay when evaluating 
      patient samples with different concentrations of adalimumab. CONCLUSION: Our 
      assay can quantify both sub-therapeutic and therapeutic concentrations of 
      bioavailable adalimumab in patient serum samples. This assay design provides an 
      alternative to isotope-labeled peptides approach currently adopted in targeted 
      proteomics methods.
CI  - Copyright (c) 2018 Elsevier B.V. All rights reserved.
FAU - Yang, Yifei
AU  - Yang Y
AD  - Department of Pathology, Pritzker School of Medicine, The University of Chicago, 
      Chicago, IL, United States. Electronic address: yifeiyang@uchicago.edu.
FAU - Wysocki, Emily
AU  - Wysocki E
AD  - Department of Pathology, Pritzker School of Medicine, The University of Chicago, 
      Chicago, IL, United States.
FAU - Antwi, Kwasi
AU  - Antwi K
AD  - Thermo Fisher Scientific, Tempe, AZ, United States.
FAU - Niederkofler, Eric
AU  - Niederkofler E
AD  - Thermo Fisher Scientific, Tempe, AZ, United States.
FAU - Leung, Edward K Y
AU  - Leung EKY
AD  - Department of Pathology, Pritzker School of Medicine, The University of Chicago, 
      Chicago, IL, United States.
FAU - Lazar-Molnar, Eszter
AU  - Lazar-Molnar E
AD  - Department of Pathology, University of Utah School of Medicine, Salt Lake City, 
      UT, United States.
FAU - Yeo, Kiang-Teck J
AU  - Yeo KJ
AD  - Department of Pathology, Pritzker School of Medicine, The University of Chicago, 
      Chicago, IL, United States.
LA  - eng
PT  - Journal Article
PT  - Validation Study
DEP - 20180509
PL  - Netherlands
TA  - Clin Chim Acta
JT  - Clinica chimica acta; international journal of clinical chemistry
JID - 1302422
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Tumor Necrosis Factor-alpha)
RN  - FYS6T7F842 (Adalimumab)
SB  - IM
MH  - Adalimumab/blood/pharmacokinetics/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized/immunology
MH  - Autoimmune Diseases/drug therapy
MH  - Biological Availability
MH  - Chromatography, Liquid
MH  - Drug Monitoring/*methods
MH  - Humans
MH  - Proteomics/*methods
MH  - Tandem Mass Spectrometry
MH  - Tumor Necrosis Factor-alpha/immunology
OTO - NOTNLM
OT  - Anti-drug antibodies
OT  - Bioavailable adalimumab
OT  - Quantitative and targeted proteomics
EDAT- 2018/05/13 06:00
MHDA- 2018/10/03 06:00
CRDT- 2018/05/13 06:00
PHST- 2017/12/20 00:00 [received]
PHST- 2018/05/08 00:00 [revised]
PHST- 2018/05/08 00:00 [accepted]
PHST- 2018/05/13 06:00 [pubmed]
PHST- 2018/10/03 06:00 [medline]
PHST- 2018/05/13 06:00 [entrez]
AID - S0009-8981(18)30224-9 [pii]
AID - 10.1016/j.cca.2018.05.015 [doi]
PST - ppublish
SO  - Clin Chim Acta. 2018 Aug;483:308-314. doi: 10.1016/j.cca.2018.05.015. Epub 2018 
      May 9.